AccessGUDID - DEVICE: Weight Bear (00860012977406)

GUDID

Device Identifier (DI) Information

Brand Name: Weight Bear
Version or Model: OI-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orthios Innovations Llc

Primary DI Number: 00860012977406
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 119315375 *Terms of Use

Device Description: A device for simulating a weightbearing position on a patient's foot during surgery or in a clinical setting.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40900	Radiological arm/leg positioner	A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	Support, Patient Position

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85f4cc5e-5654-49ee-bf4a-96c57b1c0e76
Public Version Date: November 15, 2024
Public Version Number: 2
DI Record Publish Date: October 16, 2024